跳至主要内容
临床试验/NCT02387333
NCT02387333Unknown2 期

Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion: A Randomized Controlled Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
40
试验地点
2
主要终点
Incidence of parastomal hernia 2 years after surgery

研究概览

简要总结

The aim of this clinical trial is to investigate the safety and efficacy of prophylactic mesh on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a randomized controlled fashion.

详细描述

All patients will be recruited from the urology practice of the study's investigators, Urology department of Urology and Nephrology Center (UNC), Mansoura university, Egypt. Patients will be asked to participate after the patient and physician have made a decision that ileal conduit urinary diversion of choice. Those patients meeting all inclusion criteria will be asked to participate in this study with informed consent then obtained. No monetary income will be offered for participation in the study.

Those patients will be evaluated clinically and radiologically according to the specified protocol.

After enrollment in the study, the stoma site will be marked on the skin the day prior to surgery by the stoma therapist. All patients will be operated by high volume surgeon experienced in IC urinary diversion. The procedure started by radical cystectomy and bilateral pelvic lymphadenectomy. After sparing the distal 15 cm of the terminal ileum, a 15 cm ileal segment will be isolated and the bowel continuity will be restored and the mesenteric defect will be closed. The distal end of the isolated bowel segment will be mobilized and exteriorized at the predetermined site on the abdominal wall followed by stoma eversion. A preferred rectal muscle splitting approach is preferred for IC exteriorization. In case of MSRT, dissection of subcutaneous fat off the rectus sheath will be accomplished to create a potential space for mesh placement. Then, 5 x 5 cm polypropylene mesh will be placed and incised at the center to create an orifice to allow IC exteriorization. The mesh is then fixed to underlying rectus sheath with 1-0 non-absorbable proline sutures. The IC is exteriorized through the central orifice and then fixed to the peritoneum and to the cut-edges of the rectus muscle using 3-0 polyglactin sutures. A 12 CH subcutaneous tube drain will be fixed and the subcutaneous tissue is closed to collapse the dissected space around the mesh. The stoma is then everted and fixed to the skin. Sham group patients will undergo the same technique without mesh placement. The ureters will be mobilized and anastomosed to the proximal end of the conduit using direct ureteroileal anastomosis.

All patients will undergo the routine protocol at the investigators' center including enrollment in fast track restoration of bowel habits, ileal conduit catheter to be removed on the 5th day and the ureteral stents on the 7th and 8th days. Any deviation from normal postoperative course will be recorded using the modified Clavien-Dindo system.

At followup, patients will be asked to attend the outpatient clinic at 1, 3, 6, and 12 months after discharge clinically and radiologically to assess the intended outcomes of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to give informed consent.
  • Patients with history of chronic liver disease
  • Patients with history of systemic chemotherapy, radiotherapy or maintenance on systemic corticosteroids
  • Patients with chronic causes of increased intra-abdominal pressure as chronic cough (COPD) or chronic constipation
  • Patients with surgical history of hernia repair
  • Patients with body mass index (BMI) more than 30 kg/m2
  • Patients with other hernias (inguinal, umbilical or incisional) at preoperative evaluation
  • Patients with low serum albumin < 3 gm/dl
  • Patients who will be highly candidates for adjuvant or palliative chemo-radiotherapy such those with histopathologically proved residual tumor

排除标准

  • Inability to give informed consent.
  • Patients who documented previous allergic reaction to synthetic mesh.

研究组 & 干预措施

Study group

Experimental

in this arm -study group- : patients will receive mesh stoma reinforcement technique with ileal conduit urinary diversion.

干预措施: Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion (Procedure)

Control group

Sham Comparator

in this arm -sham comparator- : patients will not receive mesh stoma reinforcement technique with ileal conduit urinary diversion.

干预措施: Ileal conduit urinary diversion (Procedure)

结局指标

主要结局

Incidence of parastomal hernia 2 years after surgery

时间窗: 2 years

The primary outcome of this study will be the incidence of parastomal hernia at 2 years after surgery

次要结局

  • Adverse events related to mesh placement(2 years)
  • Health related quality of life as measured by Body Image Scale (BIS) questionnaire(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Abdel-Lateif El-Sawy

Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Mansoura University

研究点 (2)

Loading locations...

相似试验